Senior Manager, Clinical Trial Transparency & Disclosure

Moderna Theraputics-posted 2 months ago
Full-time • Senior
Remote • Massachusetts, MA
5,001-10,000 employees
Professional, Scientific, and Technical Services
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The Senior Manager of Clinical Trial Transparency & Disclosure is a high-impact role, reporting directly to the Director of CTTD. The chosen individual will not just be responsible for Plain language Summaries but will excel in delivering other transparency and disclosure deliverables, from the meticulous planning and coordination stage to the delivery of the final products. As Senior Manager of CTTD, you will be more than a team member you will be a crucial pivot in our clinical development team, deeply understanding and appreciating how your work significantly influences the broader objectives of our clinical development programs.

  • Apply an in-depth conceptual and practical knowledge of concepts, theories, and principles of transparency & disclosure within all clinical development programs.
  • Develop and manage comprehensive, strategic document plans for clinical and regulatory submissions.
  • Oversee the timely and efficient progress of disclosure deliverables, ensuring that all deadlines are met.
  • Work closely with cross-functional teams to ensure alignment and integration of clinical and regulatory documents.
  • Ensure all written documents comply with regulatory, industry, and corporate guidelines and standards.
  • Interpret and present clinical data and other complex information.
  • Implement and oversee quality control processes for authoring and reviewing clinical and regulatory documents.
  • Regularly update and revise study details on global registries as necessary to reflect current information and meet regulatory requirements.
  • Solve complex problems; take a new perspective on existing solutions; exercise judgment based on the analysis of multiple sources of information.
  • Provide input into goals and objectives for the CTTD team that align with the company's overall strategy.
  • Responsible for management of direct reports (if applicable)
  • Advanced degree (preferred) with approximately 4 years of relevant experience OR bachelor's degree with approximately 9 years of relevant experience.
  • Proven experience in plain language summary of registration and results (Ct.gov; CTIS) and authoring disclosure documents for submission to global authorities.
  • Excellent interpersonal skills, with the ability to guide others either internally with other areas or externally with vendors and cross-functional team members to adopt a different point of view.
  • Ability to manage the daily activities of multiple supervised individuals; adapt functional plans and priorities to meet short-term service and/or operational objectives.
  • Knowledge of best practices and how CTTD integrates with others within organization sub-function; is aware of the competition and the factors that differentiate them in the market.
  • Exceptional written and verbal communication skills, with the ability to clearly convey complex scientific information.
  • Commitment to quality, ensuring that all work produced meets the highest standards of accuracy and comprehensiveness.
  • Proficiency in Microsoft Office and familiarity with Disclosure software and tools.
  • Daily on-site catered lunches [Cambridge] On-site subsidized cafeteria [Norwood]
  • Company-provided iPhone
  • Free parking, monthly subway pass or a subsidized commuter rail pass
  • Free annual corporate membership to Bluebikes
  • Highly competitive healthcare coverage including: medical offered through BCBS (HMO/PPO), dental, and vision offered through VSP
  • Flexible Spending Accounts for medical expenses and dependent care expenses
  • 16 weeks of 100% paid parental leave for all new parents
  • 16 weeks 100% paid family caregiver leave
  • 20 weeks 100% paid medical leave
  • Eligible for 'Moderna Month' (one month paid sabbatical after five years of service and eligible for additional one month paid sabbatical every 3 years thereafter)
  • Adoption assistance and discounts to local childcare centers, as well as access to care.com
  • 401k (traditional and Roth offered) with 50% match on first 6% deferred. Match is vested immediately
  • A suite of Moderna paid insurance coverage, including: life insurance, short-term and long-term disability
  • Voluntary legal assistance plan
  • 15 days' vacation and 7 sick days per year, in addition to a discretionary winter shut down and 11 company paid holidays (includes 2 floating holidays)
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